Probiotics in Infants With Gastroschisis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316510
Recruitment Status : Unknown
Verified January 2015 by University of California, Davis.
Recruitment status was:  Recruiting
First Posted : March 16, 2011
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):
University of California, Davis

March 14, 2011
March 16, 2011
January 26, 2015
March 2011
March 2015   (Final data collection date for primary outcome measure)
Composition of the fecal microbiota [ Time Frame: every two weeks for 6 weeks ]
Stools will be collected from messy diapers.
Same as current
Complete list of historical versions of study NCT01316510 on Archive Site
Length of hospital stay [ Time Frame: Initial discharge from the hospital ]
Number of days from surgery until discharge
Same as current
Not Provided
Not Provided
Probiotics in Infants With Gastroschisis
Probiotics in Infants With Gastroschisis
Infants born with gastroschisis usually require surgery shortly after birth. After surgery the intestine is often unable to digest human milk or formula for weeks or months. During this time the baby has to remain in the hospital to receive special nutrition through an IV. How bacteria colonize the intestine in these babies is unknown. Probiotics are bacteria that appear to have beneficial effects on digestion. This study will test whether giving probiotic bacteria to babies after surgery for gastroschisis will change the bacteria in the intestine to be more like those of a healthy breast-fed baby.
Infants with gastroschisis have decreased intestinal motility. This decrease in intestinal motility delays the introduction and advancement of feeds which prolongs hospitalization. The use of probiotic bacteria may improve intestinal motility. It is unknown whether the intestinal microbiota of infants with gastroschisis differs from that of healthy infants without gastroschisis and whether probiotics will change the microbiota. The primary outcome in this study is the composition of the fecal microbiota in infants with gastroschisis following surgical correction treated with Bifidobacterium infantis or placebo. We will also look at differences in hospital length of stay.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Dietary Supplement: Bifidobacteria infantis
    1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge
  • Other: Placebo
    Dilute Nutramigen formula
  • Active Comparator: Bifidobacteria infantis
    1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge (whichever happens first)
    Intervention: Dietary Supplement: Bifidobacteria infantis
  • Placebo Comparator: Placebo
    A dilute formulation of the elemental formula Nutramigen (diluted to look like the probiotic arm).
    Intervention: Other: Placebo
Powell WT, Borghese RA, Kalanetra KM, Mirmiran M, Mills DA, Underwood MA. Probiotic Administration in Infants With Gastroschisis: A Pilot Randomized Placebo-Controlled Trial. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):852-857. doi: 10.1097/MPG.0000000000001031.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2015
March 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gastroschisis
  • Born at or transferred to UC Davis Children's hospital

Exclusion Criteria:

Sexes Eligible for Study: All
up to 2 Weeks   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Mark A Underwood, MD UC Davis
University of California, Davis
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP